Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Superpotent Drug: Stability failure for assay at 6 months test time-point.
Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Reason Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine…
Reason CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good…
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